Ezfil A3

GUDID 08806387894186

Dental composite resin is a device intended to restore carious lesions or structural defects in teeth. Ezfil is indicated for Class 1, 2, 3, 4, 5 restorations, Core-buildup to replace missing tooth structure, Diastema closures, Direct veneers, Composite and porcelain repairs. The color is 18 colors with A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, OP and TL.

Meta Biomed Co., Ltd.

Dental composite resin

• Primary Device ID: 08806387894186
• NIH Device Record Key: 7f2ea084-bd47-4a0c-b359-1fdefed48334
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ezfil A3
• Version Model Number: 9418
• Company DUNS: 688322841
• Company Name: Meta Biomed Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806387894186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191991

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-23
• Device Publish Date: 2020-03-15

Devices Manufactured by Meta Biomed Co., Ltd.

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• 08806387860051 - Jet Flow Bulk A1: 2024-11-25 - Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent ena
• 08806387860068 - Jet Flow Bulk A2: 2024-11-25 - Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent ena
• 08806387860075 - Jet Flow Bulk A3: 2024-11-25 - Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent ena
• 08806387860136 - Jet Flow Bulk Dentin: 2024-11-25 - Jet Flow Bulk is a low viscosity, visible-light activated, flowable. This low stress flowable material is semi-translucent ena
• 08806387860129 - EZ Bond Universal (EZB50): 2024-06-13 EZ Bond Universal is dentin adhesion system that functions as a conditioner, primer and adhesive resin in a single component. EZ
• 08806387860105 - CeraPutty CP10: 2023-11-23 CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent
• 08806387860112 - CeraPutty CP05: 2023-11-23 CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent